Plerixafor 24 mg/1.2mL
Plerixafor · INJECTION, SOLUTION · Bryant Ranch Prepack
Plerixafor is a injection, solution containing plerixafor at 24 mg/1.2mL, taken subcutaneous. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Plerixafor
- Generic Name
- Plerixafor
- NDC Code (Product)
72162-2642- Manufacturer
- Bryant Ranch Prepack
- Strength
- 24 mg/1.2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA211901
- Drug Class
- Hematopoietic Stem Cell Mobilizer [EPC]
- Marketing Start
- 07/25/2023
Recall History
Sanofi-Aventis U.S. LLC
Labeling: Incorrect or Missing Package Insert
Genzyme Corporation / Genzyme Biosurgery
Labeling: Incorrect or Missing Lot and/or Exp. Date
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Plerixafor injection is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM). Plerixafor injection, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initiate plerixafor injection treatment after the patient has received filgrastim once daily for 4 days. ( 2.1 ) Repeat plerixafor injection dose up to 4 consecutive days. ( 2.1 ) Dose based on patient weight Less than or equal to 83 kg: 20 mg dose or select dose based on 0.24 mg/kg actual body weight. ( 2.1 ) greater than 83 kg: select dose based on 0.24 mg/kg actual body weight. ( 2.1 ) Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis. ( 2.1 ) Renal impairment: If creatinine clearance is ≤50 mL/min, decrease dose by one-third to 0.16 mg/kg. ( 2.3 ) 2.1 Recommended Dosage and Administration Begin treatment with plerixafor injection after the patient has received filgrastim once daily for 4 days [see Dosage and Administration (2.2) ] . Administer plerixafor injection approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. The recommended dose of plerixafor injection by subcutaneous injection is based on body weight: 20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing less than or equal to 83 kg. [see Clinical Pharmacology (12.3) ] 0.24 mg/kg of body weight for …
Contraindications
4 CONTRAINDICATIONS Plerixafor injection is contraindicated in patients with a history of hypersensitivity to plerixafor [see Warnings and Precautions (5.1) ] . Anaphylactic shock has occurred with use of plerixafor. History of hypersensitivity to plerixafor. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Anaphylactic shock and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Potential for tumor cell mobilization in leukemia patients [see Warnings and Precautions (5.2) ] Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.3) ] Potential for tumor cell mobilization [see Warnings and Precautions (5.4) ] Splenic enlargement [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥10%) reported in patients who received plerixafor in conjunc…
Frequently Asked Questions
What is Plerixafor used for?
Plerixafor contains Plerixafor. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Plerixafor a controlled substance?
Plerixafor is not classified as a controlled substance by the DEA.
What is the generic name for Plerixafor?
The generic name for Plerixafor is Plerixafor. There are 4 other brand versions of Plerixafor.
What is the NDC code for Plerixafor 24 mg/1.2mL?
The NDC (National Drug Code) for Plerixafor 24 mg/1.2mL is 72162-2642, listed by Bryant Ranch Prepack.